Prescription compliance device and method of using device

ABSTRACT

A prescription compliance device which aids patients in complying with instructions given by a physician for taking prescription medication. The device reminds a patient when the next dose of medication is to be taken and indicates whether a specified dose has been taken. The device includes a microcontroller, a display, a program memory for storing pre-programmed medication-taking regimens for single and multiple medications, a real time clock, a selector for selecting one of the regimens and for programming the device as to the time and day on which a first dose of medication is to be taken, a display which alternately displays the current time and a time at which a next dose of medication is to be taken and an alarm which alerts the patient at times when a dose of medication is to be taken. The selector includes an event switch which is activated by the patient after taking a dose of medication so as to record the taking of medication and to cause the microcontroller to effect the display of the next time at which a dose of medication is to be taken. A memory may also be included to record the times at which a patient takes doses of medication. The device also includes a remote programming feature via a wireless link.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation application of, and is based upon andclaims the benefit of priority under 35 U.S.C. §119(e) from, U.S.application Ser. No. 11/957,191, filed Dec. 14, 2007, which is aContinuation Application of U.S. Pat. No. 7,330,101 issued on Feb. 12,2008, which is a National Stage Application of International ApplicationNo. PCT/US02/19940, filed Jun. 24, 2002; which claims priority to U.S.Provisional Application Ser. No. 60/299,761 filed Jun. 22, 2001; theentire contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an apparatus which aids patients in complyingwith instructions given by a physician for taking prescriptionmedication, and more particularly, to a device which is programmable inaccordance with the physician's instructions or desired regimen.

2. Discussion of the Background Art

A variety of devices have been proposed for recording intervals at whichpatients, especially those under the care of an attendant, takemedication at periodic intervals prescribed by a physician. If thepatient or his medical care provider ignores the proper instructions andrepeats the dose too frequently or fails to administer or takemedication at the proper time, the concentration of medication in thepatient's body may become too high or too low. In order to ensure thatmedications are taken at the proper time, a variety of devices, such asthe one disclosed in U.S. Pat. No. 4,361,408, have been devised togenerate audible and/or visible prompting or alarm signals that remind apatient or his caretaker to administer the correct dosages at thecorrect time. Such devices have been complex and costly, inconvenient toprogram, and have not been flexible enough in establishing varying timeintervals at which the medication needs to be administered.

SUMMARY OF THE INVENTION

Accordingly, one object of this invention is to provide a low cost, easyto use prescription compliance device that has the flexibility ofoperating in accordance with various different medication-takingintervals.

Another object of this invention is to provide a prescription compliancedevice which is easily programmable either by activating a programmer onthe device itself or by remotely programming the device via a wirelesslink. Multiple programming regimens which correspond to differentmedication-taking intervals and medication-types may also be programmedinto the device.

Yet another object of this invention is to provide a prescriptioncompliance device which records the event of taking a dose of medicationand displays the time at which the next dose of medication is to betaken.

A still further object of this invention is to provide a prescriptioncompliance device having a timer which measures the time that haselapsed since the patient last took a dose of the medication and analarm which is activated at times when the patient is to take the nextdose of medication.

A further object of this invention is to provide a prescriptioncompliance device that maintains a count of the number of dosesremaining in a patient's prescription and displays the count so that apatient will know when to have the prescription refilled.

Another object of this invention is to provide a prescription compliancedevice that alerts a patient when the patient has missed a scheduleddose of medication or has taken a dose of medication at a non-scheduledtime.

Yet another object of this invention is to provide a prescriptioncompliance device which records the times at which a patient takes eachdose of medication in a format that can be easily accessed.

Another object of the invention is to provide a prescription compliancedevice which aids in the management of a multitude of medications.

These and other objects are accomplished by a prescription compliancedevice which includes a microcontroller, a program memory which storesdata representing a plurality of pre-programmed medication-takingregimens for single and multiple medications, an oscillator whichcontrols timing functions of the device, a selector selecting one of theregimens and programming the device in accordance with the selectedregimen, a display which alternately displays the current time, the timeat which a next dose of medication is to be taken in accordance with theregimen selected by the selector, and the number of doses remaining in aprescription, and an alarm which alerts the patient at times when thepatient is scheduled to take a dose of medication. The device may alsoinclude a memory which records the times at which a patient takes eachdose of medication in a format that can be easily accessed.

The selector includes an event switch which is activated by the patientafter taking a dose of medication to record the taking of themedication, the event switch causing the microcontroller to effect thedisplay of the next time at which a dose of the medication is scheduledto be taken, in accordance with the regimen selected by the selector.

The event switch and a function button are provided for programming theregimens by which the medication is to be taken, the day of the week onwhich the first dose is to be taken, the time at which the first dose isto be taken or the designation of meals during which the first dose isto be taken, and the number of doses in a patient's prescription.

Programming may be done either directly by using the function button andthe event switch or remotely via a wireless link. To program from aremote location, the device is provided with a wirelesstransmitter/receiver and an external wireless transmitter/receiverconfigured to be connected to an input device. The external wirelesstransmitter/receiver communicates with the wireless transmitter/receivervia a wireless link to select one of the regimens and to program thedevice in accordance with the selected regimen.

The display includes a first display area which alternately displays thealerts, alarms and notifications, menu selections and other information,a second display area which alternately displays the name of themedication the name of the regimen or other information, a third displayarea which alternately displays the day of the week and time in additionto other information, a fourth display area which provides special alertmessage in addition to other information. Further, for each of the abovelisted display areas, other information may include the calendar date,the patient name, the patient phone number, and icon indicating thenature of the information currently displayed in the other displayareas, AM, PM designations, historical data stored in the device memory,codes describing displayed information, advise on how medications is tobe taken, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the invention and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIG. 1 is an illustration of a prescription compliance device inaccordance with a first embodiment of the present invention;

FIG. 2 is a block diagram of a prescription compliance device of FIG. 1;

FIGS. 3A-3E are flow diagrams illustrating the steps followed whenoperating the prescription compliance device;

FIG. 4 is a table listing examples of common medication-taking regimenswhich may be programmed into the prescription compliance device;

FIG. 5 is an illustration of a prescription compliance device inaccordance with a second embodiment of the present invention;

FIG. 6A is a flow diagram illustrating the menu choices available to theuser;

FIGS. 6B-6H are flow diagrams illustrating the steps followed whenoperating the menu options shown in FIG. 6A;

FIG. 7 is a block diagram of a prescription compliance device includinga memory for recording the takings of medication and wirelessprogramming capabilities;

FIG. 8A illustrates the prescription compliance device according to thepresent invention as a free standing device;

FIG. 8B illustrates a top view of the prescription compliance device andattachment mechanism according to the present invention;

FIG. 8C illustrates a cross-sectional view of the prescriptioncompliance device attached to a bottle according to the presentinvention;

FIG. 9 is another table listing examples of common medication-takenregimens which may be programmed into the prescription compliancedevice;

FIG. 10 is an illustration of a prescription compliance device inaccordance with a fourth embodiment of the present invention;

FIG. 11 is a flow diagram illustrating menu choices available to theuser;

FIG. 12A-12B illustrates an operation of the NEXT and TAKE menu options;

FIGS. 13A-13E illustrate an operation of the EARLY menu option;

FIG. 14 illustrates an operation of the VIEW menu option;

FIGS. 15A-18B illustrate an operation of the MED menu option;

FIGS. 19A-19D illustrate an operation of the ALARM BUZZ menu option;

FIGS. 20A-20D illustrate an operation of the ALARM CLOCK menu option;

FIGS. 21A-21D illustrate an operation of the TRIP menu option;

FIGS. 22A-22M illustrate an operation of the SET TIME menu option;

FIGS. 23A-25L illustrate an operation of the USER menu option;

FIGS. 26A-31D illustrate an operation for programming regimens;

FIGS. 32A-32C illustrate an operation of the MANUAL TAKE sub-menuoption;

FIGS. 33A-33C illustrate special notifications provided to the user;

FIGS. 34A-34F illustrate operations performed during a reset operation;

FIGS. 35A-35F illustrate operations for initiating communication with aPC; and

FIGS. 36A-36B respectively illustrate a front view and a side view ofthe prescription compliance device according to the fourth embodiment.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, wherein like reference numerals designateidentical or corresponding parts throughout the several views, and moreparticularly to FIG. 1 thereof, a prescription compliance device 1according to a first embodiment of the present invention includes afunction button 2 a, a reset button 2 b, and an event switch 4 forprogramming the device, and a display 3 for displaying the programmedinformation. The event switch 4 is activated by the patient upon thetaking of a dose of medication. Note, the reset button 2 b is shown forclarity purposes as being on the front surface of the device. However,the reset button 2 b is preferably on the back surface of the device toavoid accidentally resetting the device.

Prescription Compliance Device for Single Medications

FIG. 2 illustrates a block diagram of the prescription compliance deviceaccording to the first embodiment of the invention. The illustrated anddescribed configuration is exemplary and any desired hardwareimplementation can be used. An 8-bit microcontroller 9 such as(Microchip Part No. PIC 16C954, for example) which controls the overallfunctions of the device includes a program memory 20 for storingpreprogrammed medication-taking regimens. A 32 KHz crystal oscillator 7controls all timings of the device. The program memory 20 is preferablya dedicated chip mask read only memory (ROM), although other nonvolatilememories such as a flash memory or EEPROM may be used. The specificparameters of the microcontroller, program memory, and the oscillatorare set forth here solely for illustrative purposes and are not intendedto limit the scope of the invention. The use of equivalent elements iscontemplated within the scope of this invention.

The microcontroller receives inputs from the function and reset buttons2 a, 2 b and from the event switch 4 and controls the device functionsin accordance with the pre-programmed regimens stored in program memory20. The microcontroller 9 is connected via an 8-bit bus 21 to displaydriver 11 which drives the display 3 to display relevant information indisplay areas 31-35. The display 3 is preferably a liquid crystaldisplay (LCD) and the display driver 11 an ASIC LCD driver. Battery 12is preferably a 3 volt battery and alarm circuit 8 may visually and/oraudibly prompt the patient to take medication. However, equivalents arealso within the scope of the invention.

The operation of the prescription compliance device according to thisembodiment of this invention will now be described with reference toFIGS. 3A-3E. Patients who are under the care of an attendant areinstructed to take medication at periodic intervals as prescribed by aphysician. Upon receiving the prescription, the patient or his medicalcare provider employs the prescription compliance device to aid thepatient in complying with the instructions given by the physician.

First, the device must be switched from an OFF state to an ON state bypressing the reset button (Step S1). A “SET” icon is displayed indisplay area 35 to indicate that the device is in a setup mode. Thepatient first sets the current time (Steps S2 and S3) as follows.

The event switch 4 is pressed and the microcontroller 9 directs thedisplay area 33 to blink hour digits “12”. Hours “1” through “12” arescanned through by pressing the event switch 4 and the appropriate houris selected by pressing the function button 2 a when that hour isdisplayed.

The minutes tenth digit then blinks “0” and the digits “0” through “60”are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2 a when that digit isdisplayed.

The minutes unit digit then blinks “0” and the digits “0” through “9”,are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2 a when that digit isdisplayed.

The display area 34 then blinks “A” and the patient selects AM or PMtime designations using the event switch 4 to toggle between the two andthe function button 2 a to select. This completes the setting of thecurrent time.

The patient now selects the regimen by which the prescription medicationis to be taken. Upon depressing the event switch 4, the display area 35displays “RGMN” and the display area 31 blinks “0”, prompting thepatient to scan through and select a desired regimen using the eventswitch 4 (Step S4). FIG. 4 lists examples of common programming regimenswhich may be pre-programmed into program memory 20. These regimens arelisted only by way of example and other regimens are possible.

In FIG. 4, regimens are provided for taking the medication 1, 2, 3, 4,or 6 times daily, taking the medication with breakfast and dinner, withbreakfast, lunch, and dinner, or with breakfast, lunch, dinner, and atbedtime, and for taking the medication once every 48 hours.

The patient presses the event switch 4 to advance through theprogramming regimens. During scanning, regimen numbers appear in displayarea 31 and descriptions of the regimens appear in display area 35 sothat the patient knows which regimen each number corresponds to. Forexample, when “8” appears in display area 31, “3:D” appears in displayarea 35 to indicate to the patient that programming regimen 8corresponds to taking medication three times daily.

When the desired regimen is displayed, the function key 2 a is pressed(Step S5) and the display 3 prompts the patient to choose betweenstandard, pre-programmed default times corresponding to the selectedregimen or setting a specific time at which the first dose is to betaken. If the default times for taking the medication are acceptable,the patient presses the event switch 4 and is then prompted to enter thenumber of doses in the prescription (Step S21).

If the patient instead wants to set the time at which the first dose isto be taken, the microcontroller 9 directs the display area 33 to blinkhour digits “12”. Unless the patient selects one of the meal regimens,the time of day at which the first dose of the medication is to be takenis next programmed (Steps S6 and S7). Hours “1” through “12” are scannedthrough by pressing the event switch 4 and the appropriate hour isselected by pressing the function button 2 a when that hour isdisplayed.

The minutes tenth digit then blinks “0” and the digits “0” through “60”are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2 a when that digit isdisplayed.

The minutes unit digit then blinks “0” and the digits “0” through “9”are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2 a when that digit isdisplayed.

The display area 34 then blinks “A” and the patient selects AM or PMtime designations using the event switch 4 to toggle between the two andthe function button 2 a to select. This completes the setting of thetime at which a first dose of medication is to be taken by the patient.

If one of the meal regimens is selected, the medication is to be takenwith meals the times of which will vary from person to person. Theprogram memory 20 has pre-programmed therein standard meal times(breakfast, lunch, dinner) during which most persons normally eat.However, the device is flexible enough to allow for different mealtimes, as will now be explained.

After a meal regimen is selected, display area 33 blinks “D” for defaultmeal times. If the patient eats meals at the standard times programmedinto the program memory 20, then the function button 2 a is pressed when“D” is displayed (Step S8). If the patient eats at different times, thenpressing the event switch 4 (Step S9) allows the patient to togglebetween “D” and “S” (indicating ‘set’). Pressing the function key 2 awhen “S” is displayed (Step S10) allows the user to set his breakfast,lunch, dinner, and bedtimes as follows. After the function key 2 a ispressed, “BRKF” appears in display area 35 and “12” blinks in displayarea 33. The patient's breakfast time (hour, minute, AM/PM) is enteredas described above (Steps S11 and S12).

After programming the breakfast time, the operation varies according tothe specific regimen selected. For explanatory purposes, regimens 1, 2,and 3 refer to the meal designations listed in FIG. 4. If regimen 2 or 3has been selected, “LNCH” appears in display area 35 and the timesetting process is repeated to set the patient's lunch time (Steps S13and S14). “DINR” then appears in display area 35 under regimens 1, 2,and 3 and the patient's dinner time is similarly set (Steps S15 andS16). Finally, “BDTM” appears in display area 35 if regimen 3 isselected and the patient's bedtime is set as described above (Steps S17and S18).

Once the time/meal designations have been programmed, the display area32 then blinks “SU”, prompting the patient to program the day of theweek on which the first dose is to be taken. The days “SU” through “SA”are scanned through by pressing the event switch 4 (Step S19) and theappropriate day is selected by pressing the function button 2 a (StepS20).

The display area 35 then displays “CNT,” prompting the patient to enterthe number of doses in the current prescription. Display area 33 blinks“0” and the patient scans up using the event switch 4 until the desirednumber is displayed (Step S21). The function button 2 a is then pressedto select this number (Step S22).

The display area 35 then prompts the patient to enter the number of daysthat the current prescription is scheduled to last. Display area 33blinks “0” and the patient can scan up using the event switch 4 untilthe desired number is displayed (Step S23). The function button 2 a isthen pressed to select this number (Step S24).

This completes the setup process. Display area 35 next displays “STRT”and display area 33 displays a question mark (“?”). When the userpresses the event switch 4, the device is in an operation mode (StepS25). The operation mode is defined a mode the device resides in afterthe user has programmed the desired options. Display 3 may alternatelydisplay the current time or the time at which the next dose is to betaken. When the current time is displayed, display area 35 displays“TIME,” display area 31 displays the number of the regimen selected bythe patient, display areas 33 and 34 display the current time of day,and display area 32 displays the current day of the week. When the timeof taking the next dose of medication is displayed, display areas 33 and34 display the time at which the next dose is to be taken, display area32 displays the day of the week on which the next dose is to be taken,display area 31 continues to display the number of the selected regimen,and display area 35 displays “NEXT.”

After the device is programmed and the event switch 4 is pressed toenter the operation mode, the patient is aware of the day and time atwhich the first dose of the medication must be taken. At the time fortaking the first dose, the microcontroller 9 directs the alarm circuit 8to emit an audible and/or visible signal to alert the patient that thefirst dose must be taken at this time (Step S26). The alerting signalcontinues to be emitted intermittently until the patient takes the doseand presses the event switch 4 or until a prescribed time has elapsed(Step S27). During this time, display area 35 displays “TAKE” indicatingthat it is time to take the next dose. If the patient takes the dosemore than a prescribed time before the scheduled time and presses theevent switch 4, the alarm circuit 8 is activated (Step S28) and thedisplay area 35 indicates “ERR” (Step S29) to indicate that the patienthas not properly followed the selected regimen.

If the patient fails to take the dose within a prescribed time after thescheduled time while the alarm circuit 8 is activated, display area 35displays “MISS” (Step S34) indicating that the patient has missed takingthe scheduled dose. The display then indicates the time that the misseddose was scheduled to be taken (Step S35) and prompts the patient todirect the device as to how to proceed (Step S36). At this point thepatient may press the event switch 4 to maintain the current regimen(Step 37) or may select a new regimen (Step S38).

Upon taking the first dose, the patient presses the event switch 4 whichrecords the taking of the medication and causes the microcontroller toautomatically calculate the time/meal at which the next dose ofmedication must be taken according to the selected regimen and to effectthe display of this time on the display 3 (Step S39). Themicrocontroller also subtracts the dose taken from the total number ofdoses in the prescription to update the count of remaining doses. Thisnumber is displayed in display area 33 while “LEFT” is displayed indisplay area 35 to indicate the number of doses remaining (Step S40).

Likewise, at the end of each day the microcontroller subtracts one fromthe total number of days in the prescription to update the count ofremaining days. This number is displayed in display area 33 to indicatethe number of days remaining (Step S41).

These operating procedures are repeated for as long as the patient'sprescription is valid. When the number of doses in the prescription hasbeen nearly exhausted (i.e., six doses or less remaining), the displayindicates “FILL” and the alarm circuit is activated (Step S42). If thepatient has the prescription refilled at the direction of a physician,the operating procedures are resumed at Step S21. Otherwise, if thepatient has completed his prescription and needs no further medication,the device is turned off by pressing the reset button 2 b (Step S43).

Prescription Compliance Device for Multiple Medications

FIG. 5 illustrates a block diagram prescription compliance deviceaccording to a second embodiment of the invention. In this embodiment,the user may program the device and monitor the status of multiplemedications.

In addition to the central processor and supporting circuitry shown inFIG. 2 for the first embodiment, the device 50 according to the secondembodiment includes a display 51 and a key pad 52. The display 51includes eight character and/or graphical display fields F1-F8 whichdisplay information to the user. This information could also bepresented using a dot matrix display and/or a scrolling display.Exemplary manners of implementing the display include using a liquidcrystal display (LCD), a cathode ray tube (CRT), or a plasma display.

Referring to FIG. 5, the field F1 informs the user if multiplemedications are to be taken, F2 informs the user of the specificprescription regimen being used with the medicine identified in F6 andF7, and F3 informs the user as to the status of the alarm or vibrator.When the device 50 is in an “OPERATE” mode, F4 informs the user whetheror not to take a medication. If the user is to take a medication, F4displays the word “TAKE,” otherwise F4 displays the word “NEXT.” An“OPERATE” mode is defined as a mode in which the device normally resideswithout an action on the part of the user. During a menu scan operation,the field F4 informs the user of the various options available. Thefield F4 also provides other information necessary to inform user of thenature or status of information that is being provided in the otherfields. The field F5 displays time information, such as the day of theweek, hour, minute, and AM or PM, and F6 is an optional character fieldidentifying a memory slot relating to a specific medication F7 displaysuser programmed information identifying a specific medication and F8advises the user if a program for a particular medication is operativeor if it has been suspended.

As shown in FIG. 5, the device 50 also includes a keypad 52 with sixkeys: SELECT 53, MENU 54, UP 55, DOWN 56, SNOOZE 57 and EVENT 58. Otherkeys such as a numeric keypad, an alpha-numeric key pad, or a computerkeyboard may be utilized, if desired. These keys are used duringprogramming and operation of the device. The UP 55 and DOWN 56 keysallow the user to scroll through the options under the various menuitems and the SELECT 53 key is used to select a desired option. Failureto activate the SELECT 53 key within a prescribed time interval returnsthe device to the OPERATE mode. Successive activation of the MENU 54 keycauses the field F4 to display the menu choices shown in FIG. 6A.Pressing the SELECT 53 key while one of these options is displayed setsthe device into the specific operation mode selected. The keypad 52 maybe combined with the display 51, as illustrated in FIG. 5, oralternatively the keypad 52 may be separate from the display 51.

The multi-medicine prescription compliance device also includes a SNOOZEswitch 57 and an EVENT switch 58. For the medication that is displayedin the fields F6 and F7, pressing the EVENT switch 58 causes thefollowing events to occur. When the field F4 displays the word TAKE, thecurrent date, time, and medication name is recorded, thus signifying themedication was taken. Then the field F4 displays the word NEXT and thenext time to take the medication is displayed in the field F5. However,if other medications have earlier take times, the field F4 displays theappropriate NEXT or TAKE screen for that medication. When the field F4displays the word NEXT and the time to take the medication is within apredetermined time range, the same sequence applies as when the F4displays the word TAKE. However, when the field F4 displays the wordNEXT and the time to take the medication has exceeded the predeterminedtime range, the current clock time and day are identified with themedication and the event is recorded. If the user fails to take themedication within the predetermined time range, the device advances tothe appropriate next take time for that medication. In addition, theSNOOZE button 57 is used to silence the alarm. The alarm will then skipone interval before alerting the user again.

The operation of the prescription compliance device according to thesecond embodiment of this invention will now be described with referenceto FIGS. 6A-6H. FIG. 6A illustrates the choices available to the userwhich can be scrolled through by pressing the MENU 54 key.

The menu choices shown in FIG. 6A include the options of TIME (StepS50), VIEW (Step S60), MEDICATION (Step S70), ALARM (Step S80), LOCK(Step S90), HELLO (Step S100) and RUN (Step S110) which are explainedbelow with respect to FIGS. 6B to 6H. The user scrolls through theoptions by pressing the MENU 54 key and then selects the desired optionwith the SELECT 53 key.

FIG. 6B illustrates the programming steps required to display or editthe current time. After the TIME option is selected (Step S50) in FIG.6A, the user has a choice to display the current time or edit thecurrent time (Step S51). If the user chooses to display the current timein Step S51 and executes the RUN option (Step S53), the current timewill be displayed in the field F6 (Step S54) and the device returns tothe OPERATE mode. If the user chooses to edit the current time in StepS51, the user scrolls through the times (days, hours, minutes) andselects a desired time (Step S52). After executing the RUN option (StepS53), the edited time will be displayed in the filed F6 and the devicereturns to the OPERATE mode.

FIG. 6C illustrates the programming steps to view the differentmedications programmed into the device. After the VIEW option isselected (Step S60) in FIG. 6A, the user scrolls through the times thatvarious medications are to be taken (Step S61). The time the medicationis to be taken is displayed in the field F5 and the medicine identifiersare displayed in the fields F6 and F7. The user then selects the RUNoption (Step S62) to return the device to the OPERATE mode.

FIG. 6D illustrates the programming steps to view, omit or customize aspecific medication. After the MEDICATION option is selected (Step S70)in FIG. 6A, the user scrolls through and selects one of the variousmedications (Step S71). Upon selecting a medication, the user scrollsthrough and selects an option (Step S72) including “LAST”, “FUTURE”,“OMIT” and “PROGRAM”. The “LAST” option (Step S73) informs the user thelast time the medication was taken. The “FUTURE” option (Step S74)allows the user to scroll through the future times the medication is tobe taken and the “OMIT” option (Step S75) allows a user to temporarilyturn off the program for the selected medication. The ON/OFF status forthe medication is displayed in the field F8. The PROGRAM option (StepS76) allows the user to set (customize) program parameters for theselected medication. FIG. 6E illustrates the programming steps requiredto set the program parameters.

After the PROGRAM option is selected (Step S76) in FIG. 6D, the userenters customized information identifying the selected medication (StepS77 a) in FIG. 6E. The customized information is displayed in the fieldF7. After Step S77 a is performed, the user selects among severalregimen options including a daily regimen (i.e., 1/Daily—once per day;2/Daily—twice a day; 3/Daily—three times a day; and 4/Daily—four times aday) (Step S77 c), and an hourly regimen in which the user selectshourly intervals to take the medication (Step 77 d). Also included are aCYCLICAL (monthly cycle), MEAL (meal time), CUSTOMIZE (customized timeintervals), and RECORD (record time at which medication was taken)regimens. Upon selecting the CYCLICAL option, the user enters the numberof days in the cycle they take the medication (Step S77 e). Then, theuser enters the days in the month (Step 77 f), the start date in themonth that the user wants to start taking medication (Step 77 g), andthe current date of the month (Step S77 h). The user also enters thetime the first dose is to be taken (Step 77 m) for the DAILY, HOURLY,and CYCLICAL regimens. After selecting the MEAL option, the user has achoice to take the medication WITH, AFTER or BEFORE meals (Step S77 j).After selecting the CUSTOMIZE option, the user enters a specific timeinterval (Step S77 k). The RECORD option (Step S771) records the timethe medication is taken. The user selects the RUN option (Step S77 n) toreturn the device to the normal operating mode.

FIG. 6F illustrates the programming steps to program the ALARM options.After the ALARM option (Step S80) is selected in FIG. 6A, the userselects a low, high or vibrator ALARM (Step S81). The user then selectsthe RUN option (Step S82) to return the device to the normal operatingmode.

FIG. 6G illustrates the programming steps required to program the LOCKoption. After the LOCK option (Step S90) is selected in FIG. 6A, theuser has the choice to lock or unlock the programming features of thedevice (Step S91). If the user wants to lock the programming features,the user enters a code in Step S93. The code may include any combinationof numeric or character values. If the user chooses to unlock theprogramming features, the user enters the code to unlock the device(Step S92). The user then selects the RUN option (Step S94) to return tothe device to the OPERATE mode.

FIG. 6H illustrates the programming steps required to program the HELLOoption. After the HELLO option is selected (S100) in FIG. 6A, the usermay enter phone and name information or meal time information (StepS101). If the user chooses to enter phone and name information, the userenters the desired phone and name information (Step S1102) then has achoice to enter another name and phone number (Step S104). If the userdesires to enter another phone and name number (Yes in Step S104), theprogramming procedure returns to Step S102. If the user does not wish toenter any more phone and name numbers (No in Step S104), the userselects the RUN option (Step S105) and the device returns to the OPERATEmode. If the user chooses to enter meal time information in Step S101,the user enters the desired meal times for breakfast, lunch, and dinnerin Step S103. After the desired meal time information is entered, theuser selects the RUN option in Step S105 to return the device to theOPERATE mode.

Wireless Output

FIG. 7 illustrates a third embodiment of the present invention. Sincethe programming and operation of the prescription compliance deviceaccording to this embodiment are identical in most aspects to those ofthe first and second embodiments, a description of the identicalfeatures will be omitted. Referring to FIG. 7, the prescriptioncompliance device further includes a wireless transmitter/receiver 40(Microchip Part No. SFH485) which communicates with an external wirelesstransmitter/receiver 41 via a wireless link (not shown). The externalwireless transmitter/receiver 41 includes a wirelesstransmitter/receiver 42 and an interface 43 for connection to an inputdevice, such as a personal computer (PC). The interface is preferably astandard RS-232 serial interface, and infrared technology is employed inthe preferred embodiment to transmit and receive information. Thepersonal computer runs software by which the device may be programmedvia the personal computer instead of directly programming using thefunction buttons. The above-described programming procedures for thefirst and second embodiments are carried out in this embodiment on apersonal computer. Programming the device is thus made more convenientby simply inputting the above-described parameters (time, meals, numberof pills, etc.) via a personal computer keyboard.

The information input by the patient or his medical care provider via apersonal computer is transmitted by the wireless transmitter/receiver 42and received by the wireless transmitter/receiver 40 and processed justas if it were directly input via the buttons described for the first andsecond embodiments. The wireless transmitter/receiver 40 transmits backto the external device the current status of the device and theinformation displayed on the display 3,51.

The device of FIG. 7 also includes a non-volatile memory 10 whichrecords the taking of each dose of medication by the patient when theevent switch 4,58 is pressed. Information as to which doses have beentaken is accessible via the wireless link so that a physician canexamine the patient's compliance in taking the medication. Thenon-volatile memory 10 of the preferred embodiment is an 8 KB serialEEPROM (Microchip Part No. 24LC08B), however equivalent memories may beemployed without departing from the scope of this invention. Afterprogramming the device on a personal computer, the patient's operationof the device is identical to that described above for the first andsecond embodiments.

The wireless transmitter/receiver 40 preferably utilizes Amplitude ShiftKeying (ASK) modulation to transmit/receive infrared energy to/from theexternal wireless transmitter/receiver. Infrared technology has beendisclosed merely for illustrative purposes and other wirelesstechnologies and modulation methods are contemplated to be within thescope of the invention.

In addition, each prescription compliance device has a uniqueidentification number assigned thereto and stored in its program memory20 for the purpose of identifying a particular device when programmingfrom a remote location.

With regard to programming the device, parameters such as the day, timeof day, and other parameters may be set in a global register, whereasmedication specific parameters are programmed within a unique register.An additional capacity may be included to allow the user to review theinformation programmed into the device for each of the registers and toreview any other pertinent information. This information may be reviewedat the level of the device itself and/or through the wireless computerinterface.

The activation of the event switch 4,58 will cause temporal data to bestored in a non-volatile memory. In addition, such temporal data willhave associated with it an identifying character so that a utilizationof a specific medication or therapy can be tracked.

In addition to or as an alternative to identifying the individualregisters by characters or symbols, the device may also provideuser-friendly information, such as information identifying the specificmedication associated with a register by name or description (i.e.yellow pill, water pill, etc.). Additionally, instructions may beprovided in conjunction with an alarm providing the user with usefulinformation (i.e. take with food; avoid milk, etc.). Both types of suchadditional information would be accessible to each register to recalland display at appropriate times in either voice or character formats asdiscussed below.

The wireless emissions of the device can also be used as transducing theelements to activate secondary apparatuses. Thus, the emission of awireless signal in conjunction with an alarm can be used as a signal toactivate secondary alarms. The secondary alarms can be used to alertindividuals who are hearing or vision impaired, to alert deliverysystems to dispense medication to individuals who are mentally orphysically handicapped, or to activate any of a variety of other typesof apparatuses.

Within institutional settings, emissions from the prescriptioncompliance device which are triggered by the alarm logic, may be used inconjunction with medication or therapy dispensing stations, orsimilarly, to alert staff that the time has arrived to provide aspecific medication or therapy to a patient. Thus, according to thepresent invention, scheduling and planning of therapy regimens in thepharmacy, by the physician, or by any other care provider, may beprogrammed into the prescription compliance device. In this embodiment,the device can perform a function of instructing staff to providemedication or therapy in a prescribed manner and/or at prescribed times.

In the present invention, this prescription compliance device isequipped with a capacity for wireless emissions that are output inconjunction with activation of the event switch or passively by openingthe medicine bottle, etc. The wireless emissions carry the unique unitspecific signature and can be collected by independent receivers.Therefore, collection of emission data can be used to evaluate andmonitor the appropriate dispensing of medication and therapy, and toprovide an alert/alarm condition if serious omission or error occurs(e.g., a medication was not dispensed properly).

Wireless emission output may also be used to effect concurrent signalemission by another apparatus or device. Concurrent wireless emission bythe prescription compliance device and other apparatuses could bereceived by an independent recorder in very close time sequences, thusallowing temporal and proximity relation of action and instruments to beestablished. For example, the activation of the “Event Switch” on aprescription compliance device would emit a signal that would becollected by the independent receiver and would also cause anappropriate patient identifying device to emit a signal. This signalwould also be collected by the receiver. Through correlation of thereceiver identity, prescription compliance device identity, and patientidentity, a data set can be generated establishing a relationshipbetween a specific action, a specific place, a specific medication, anda particular patient.

Attachments

FIGS. 8A, 8B and 8C illustrate the prescription compliance deviceattached to a variety of containers and surfaces that are either flat orcurved. FIG. 5A shows the prescription compliance device as a freestanding device which is housed in a plastic casing that has anaccommodation on the back surface to permit attachment to a chain orloop that facilitates use as a key chain or pendent (not shown). Thedevice fits into a collar (A in FIGS. 8B and 8C) that are flexible andcan bend to accommodate the shape of curved containers or flat surfaces.The “wings” and back surface of the collar are coated with adhesivewhich attaches the attachment appliance to the surface or container(FIG. 8C). In applications where a narrow construct is required, the“wings” may be clipped off at points D (in FIG. 8B) and attachment tothe surface can be achieved solely through the adhesive on the back ofthe collar C (in FIG. 8C)

Thus, the prescription compliance device according to this invention maybe attached to medication containers by adhesives, straps, velcro,mechanical attachment, integration as a component of the containeritself, or by any other manner of attachment. The device also operatesfreestanding, and need not be attached to a medication container.

The device can be utilized in conjunction with or as a part of a widearray of medicine delivery systems and free standing units. Freestanding units independent of the medical container include use as, oras a part of a clock, pendent, key chain or watch. Other free standingapplications include configurations similar to those used for beepers orcellular telephones or any other similar configuration that can easilybe carried by a person. In addition to attaching the device to themedicine container or integration as a part of the medicine container,the current invention describes prescription compliance devices that canbe used with or are a part of blister packaging, medicine cabinets, pillbox or any other container intended for distributing medication.Additionally, the device can be integrated with, or used in conjunctionwith a cabinet, cart or other similar apparatus that is used inconjunction with dispensing medicine or therapy in an institutionalsetting.

Alarms

As discussed above, the device triggers circuits to alert the patientwhen to take a dose of medication. These alarm capabilities include, inaddition to audio and visual signals, tactile signaling, such as avibrator or comparable mode of signaling, voice signaling achievedthrough a recording or digital generation, and the use of a wirelessoutput as a transducing element to activate a triggering of secondarydevices (e.g., alarms, patient assistance equipment, etc.) or to alertmedical personnel or other personnel that some form of action should betaken (e.g., providing medication or therapy). The avenue via which theprescription compliance device communicates information to the userincludes tactile and visual and auditory signaling.

The use of tactile stimulation, such as the vibrator used in a pager, orsome similar stimulus will provide the user with a discrete signal thatcan alert the user without alerting others in his/her company. Operationof a tactile stimulation will occur in a manner analogous to thatdescribed for the visual and auditory stimuli.

The device according to the present invention also includes the use ofrecorded signaling to provide the user with identification and/orinstructional information. In order for prescription devices to achievethese capabilities, they may be equipped with a microphone, speaker andsolid state recording device. In the recording mode, the user canprovide vocal input regarding identification of medication and/or properusage. Utilization of user (or medical care provider) recordedinformation will occur per logic employed at the level of the device'smicroprocessor(s) and may incorporate prerecorded information inaddition to that recorded by the user. Thus, with the multi-medicinedevice described, the logic in a specific register may be used todictate playback of a recorded sequence such as “10 PM; Take YellowPills; Take with food.” Such a sequence may combine user recorded andprerecorded signaling to alert the user to therapy identification, thetime of utilization, special instructions, and any other parameters thatmight be appropriate. Such sequences are appropriately utilized withinspecific registers in multi-medication devices, thus providing the userwith the proper timing and practical advice for the correct use ofspecific medications.

In addition, a user initiated action may be required to initiate thedisplay of either visual or recorded identification and instructionalinformation. Thus, the prescription device may first emit an audio,visual or tactile stimulus, and then an action by the user will causethe device to display the appropriate audio and/or visual information.Display of such audio or visual information may be accomplished in amanner so as to preserve the privacy of the user in hearing or viewingsuch information (e.g., an ear phone).

The device is preferably configured to include six different alarmsounds. For example, when it is time to take the medication, an alarm1is sounded for approximately 15 seconds, every ten minutes. If the useris unable to take the medication, any button may be pressed to silencethe alarm. The TAKE display is also updated to display the latest TAKEat the occurrence of a new take alarm or the clock alarm. An alarm2occurs when a take event is recorded by selecting the TAKE 61 key. Analarm3 is produced when a skip event is recorded by pushing the SKIP 62key. When any menu or other selection is made by pushing the SELECT 53key, an alarm4 is sounded. An alarm5 is produced to notify the user torenew the battery or to refill a prescription. An alarm6 is produced tonotify the user that the alarm clock is active. Note the alarm typeselection only decides what type of alarm is activated at the time for a“take” event. Other audio alarms (alarm2 to alarm5 are active for bothcases, even when the vibration alarm is selected).

The alarm1 is a repeating one short, one long beep; the alarm2 is twoshort beeps; the alarm3 is one long beep; the alarm4 is one small beep;the alarm5 is two long beeps; and the alarm6 is five short beepsrepeated three times. All alarm sounds are preferably disabled for sixseconds in the case of a device power failure or when batteries arereplaced. Other alarm sounds may also be used.

Dosing Schedules

TABLE 1 summarizes dosing time intervals for morning, midday, afternoon,etc. Normally a patient is awake for 14 hours and it is over thisinterval that a patient is most likely to take medication prescribed ina given day. The 14 day is divided into a series of time intervalsdesirable for the patient to take medication. Alternatively, the dosingtime intervals may correspond to meal times (e.g., with, before, andafter breakfast, lunch, etc.).

TABLE 1 DOSAGE TIME INCREMENT TIME (example) 1^(st) (Morning) 0 hr  8 AM(first dose of day) 2^(nd) (Mid day) 4 hr 12 PM 3^(rd) (Afternoon) 7 hr 3 PM 4^(th) (Evening) 9 hr  5 PM 5^(th) (Late evening 12 hr  10 PM6^(th) (Bedtime) 14 hr  10 pm

FIG. 9 illustrates additional programming regimes which allow the userto easily adjust a mediation taken.

Utilization of the specific times generated in such a matrix as shown inTable 1 allows simple definition of appropriate times for the patient totake medication under the most common regimens identified in FIG. 9 asRegimens 1, 2, 3 and 4. Medications not prescribed by these straightforward regimens may be handled by additional regimens. Regimen 0 is afully custom regimen which allows the patient to define up to, forexample, 9 specific times in a day when medication is to be taken.Regimen 5 is designed for medications that must be taken at prescribedintervals and may accommodate intervals of up to 99 hours. Regimen 6operates to define a specific interval after taking a dose of medicationprior to which another dose should not be taken. Regimen 7 defines amonthly cycle for taking medication (i.e., the patient is advised whento and when not to take medication over the course of a month or othercycle). Regimens 8, 9, and 10 are for use with medications that are tobe taken in conjunction with meals. These regimen may have default timesof 8:00 AM, 12:30 PM, and 6:00 PM, but the patient is able to set timesappropriate for his own schedule. Regimen 11 is for use with medicationsthat are to be taken on an empty stomach. Regimen 12 defines a fixedcycle for taking medication, Regimen 13 defines start and stop dates onwhich a selected regimen is to be begin and end, and Regimen 14 definesselected days on which the medication is to be taken. Regimen 15 is arecord only mode where only activation of the event button is recorded.

Programming the regimens shown in FIG. 9 is similar to the programmingsteps described in the first and second embodiments. Briefly, to programone of the regimens in FIG. 9, the user sets the current time of the dayand selects a desired regimen number. To program regimen 0, the timesfor T1-T9 are set. The chain of times may be terminated by setting 0:00.For Regimens 1-4, the time for the first dose to be taken is set and thetake times are automatically calculated as appropriate.

For Regimen 5, the time for the first dose to be taken and the desiredtime interval is set. The time interval may be set as any number between0 and 100 or it may be selected from the sequence 1, 2, 3, 4, 6, 8, 12,24, 36, 48, 60, 72, 84, 96 hr. The take times are automaticallycalculated by adding the interval time to the first dose time or thepreviously calculated take time.

For Regimen 6, the time interval is set as any number between 0 and 100or it may be selected from the sequence 1, 2, 3, 4, 6, 8, 12, 24, 36,48, 60, 72, 84, 96 hrs. The take times are automatically calculated byadding the interval time to the time the first time or the previouslycalculated take time. When the user selects this regimen, the option isgiven to set the minimal interval in hours. The window to take themedication is active once the regimen is set, or appropriatelyactivated. When the medication has been taken, the device counts thetime integral before the take window reopens. Visual alarms for the takeevents associated with the asNEEDED (Regimen 6) regimen may be displayedas OK TAKE.

For Regimen 7, the time for the first dose to be taken is set. Then thedays on (i.e., the number of consecutive days in which the prescriptionshould be taken) is set. The days in the cycle (i.e., days in month ornumber of days), and the current date or number of days in the cycle isset. The starting date in the cycle is set and the take times areautomatically calculated. The device additionally advises the user onwhat days in the cycle medication should be taken. When the user entersthe first take time in a new cycle, the device will prompt the user toenter a new value for the day in the cycle. For example, assume the userwanted to take medication from the 16th to the 25th of each month andtoday is April 9th. In this case, Day ON=10, Days in Cycle=30, CurrentDate=9, and Starting Date=16. These take dates will repeat month aftermonth with the provision that take events don't occur after the 28^(th)day of any month. If the device is equipped with an electronic perpetualcalendar the same result can be achieved by simply entering the monthlystart and stop dates.

For Regimen 8, the user set or default time for Breakfast (8:00 AM),Lunch (12:00 PM), or Dinner (5:00 PM) are the times at which the patientis instructed to take medication. The ranges are set at 15 min beforethe mealtime up until 60 min past, for example.

For Regimen 9, the user scans and selects a default time for Breakfast(08:00 AM), Lunch (12:30 PM), and Dinner (6:00 PM) (and may alter thedefault time) and the take times are automatically calculated by adding2 hours to the selected meal times.

For Regimen 10, the user scans default times for Breakfast (08:00 AM),Lunch (12:30 PM), and Dinner (6:00 PM) (and may alter the default time)and the take times are automatically calculated by subtracting 1 hourfrom the selected meal times.

For Regimen 11, the take times are the meal times plus two hours with anacceptable range of −15 minutes to +60 minutes. With both the EMPTYSTOMACH and WITH FOOD regimens, alternative take times and take regimensmay be equally acceptable. Once either the EMPTY STOMACH or the WITHFOOD regimen is selected, the user may select between turning ON or OFFthis regimen for any given meal. The user can thus choose between takingmedication once a day in association with any meal, twice a day inassociation with any two meals, or three times a day in association withall three meals. The setting of the meal times in the device isstructured so that the minimal interval between breakfast and lunch is 4hours, the minimal interval between lunch and dinner is 5 hours, withthe additional feature that all meal times occur within a 14-hourperiod.

For Regimen 12, the user has an option to create a repeating protocol oftake days and off days. This is achieved by providing the user with theoption to select the total number of days in the cycle, starting on thefirst day of the cycle on which medication is to be taken, and which dayof the fixed cycle is today's date. Once this data has been entered, theuser is given the option to select the time of day at which time themedication is to be taken. The take range is plus or minus 4 hours.

For Regimen 13, the user is given the option to specify a start day andtime and an end day and time for any of the other regimens. When thisregimen is selected, the user is given the option to enter a month, dateand time when the regimen is to start, and also is given the option toset the month, day and time when the regimen is to end. Once theseparameters have been selected, the user is given the option to selectbetween the several regimens that are available. Subsequent programmingof the regimen is achieved by the sequence of data entry that is normalto that regimen.

For Regimen 14, the user is given the option to select on which days ofthe week to take a medication. Once this regimen is selected, the useris given the option to scan through the days of the week (i.e., Sundayto Saturday) and for each individual day to select an ON or OFF option.Once these parameters are entered, the user is given the option toselect the time of day at which the medication is to be taken. The takerange is plus or minus 4 hours.

Turning now to FIG. 10, which illustrates a block diagram of theprescription compliance device 50 according to a fourth embodiment ofthe present invention. As shown, the display fields F1-F8 shown in FIG.5 are also used in the device 50 according to the fourth embodiment.However, the key pad 52′ includes additional keys: TIME 60, TAKE 61,SKIP 62 and RESET 63. These keys are used in programming and operatingthe device in the fourth embodiment, which will now be described withreference to FIG. 11.

In more detail, FIG. 11 illustrates the choices available to the userwhich can be scrolled through by pressing the MENU 54 key. The menuchoices are displayed in the display field F1 (see FIG. 10), and includethe options of NEXT (step S200), BAT-Low (step S202), EARLY (step S204),VIEW (step S206), MED (step S208), ALARM BUZZ (step S210), ALARM CLOCK(step S212), TRIP (step S214), SET TIME (step S216) and USER (stepS218). The user may scroll through the options by pressing the MENU 54key and then select the desired option with the SELECT 53 key. Thefollowing is a description how a user operates each of the menu optionssteps S200-S218.

In more detail, FIG. 12A-12B illustrates fields F5 and F7 displayinginformation when the NEXT menu option is selected. As shown, a waterpill is next to be taken on Monday at 3:00 P.M. Note, if the battery islow, the NEXT menu option will appear as that shown in step S202 (i.e.,the display field F1 indicates the battery is low). The batteryindication occurs after the passage of certain number of days from whenthe battery was last replaced, or a low battery condition may bephysically measured, for example. Thus, the user is given the option toeither replace or recharge the batteries. If an alarm to take amedication becomes active the information in F7 and F8 shown in FIG. 12Bwill be shown. When the device alerts to take a medication the TAKE inF& will flash to bring attention to the visual alarm. The time that thealarm activated will be displayed.

FIGS. 13A-13E illustrate an operation of the EARLY menu option stepS204. As shown in FIG. 13A, when the EARLY menu option is selected, thedisplay fields F4, F5 and F7 indicate that one or more medications arewithin the early take range allowed or that possibly one or moremedications need to be renewed. Pressing the UP and DOWN keys 55, 56allow the user to scroll through the list of medications that may betaken early or that need to be renewed. FIG. 13B indicates that thereare no medications currently in the early take range, but that there isat least one medication that needs to be renewed. If the prompt “MULTI”also appears in display field F4 (see FIG. 13D), this indicates thatmore than one medication is to be renewed. The MULTI prompt disappearson the last medication requiring renewal (see FIG. 13E).

FIG. 13C illustrates that there are neither any medications in the earlytake range nor are there any medications that require renewal. If theMENU 54 key is pressed when the user is inside the EARLY take mode, thedevice returns to the EARLY menu option shown in step S204. Note, theTIME 60 key, if selected, will display the current time in display fieldF5 for 30 seconds until it is released and then the device returns tothe last displayed field. If no other key is pressed within 20 seconds,for example, the display field F1 will return to the TAKE menu option oranother appropriate default option. When the NEXT screen is activepressing TIME will cause a continuous display of the current time untilTIME or MENU is pressed, or until an alarm becomes active.

As noted above, FIG. 13D indicates there are more medications to berenewed. In addition, the multi display appears when there are multiplemedications that can be taken early. The user enters take or skip eventsinto the device by pressing either the TAKE or SKIP keys as desired. Tominimize errors the user is required to press the key twice forconfirmation. Once this has been done the device will advance to thenext medication for which an early take is active, or to a renew alert.FIG. 13E indicates this is the last medication in the renewal list (notethe MULTI prompt is not displayed).

Turning now to FIG. 14, which illustrates the operation of the VIEW menuoption step S206. In more detail, selection of the VIEW menu optioncauses the information in fields F4, F5 and F7 is displayed as shown inFIG. 14. Using the UP and DOWN keys 55, 56, the user can view theschedule for taking medications arranged in ascending chronologicalorder including appropriate time and medicine information. For example,up to a maximum of 99 future take events occurring over the next 7 dayscan be thus viewed. Returning to the NEXT display option step S200 orother appropriate screen is accomplished by a 20-second time out (i.e.,an UP or DOWN key 55, 56 is not pressed within 15 seconds). Other timeout values may also be used. Pressing the MENU 54 key returns the deviceto the VIEW display option step S206.

Turning now to the MED menu option step S208 with reference to FIGS.15A-18B. In more detail, FIG. 15A illustrates information display whenthe MED menu option is first selected. As shown, the field F4 displaysPICK MED and field F7 displays an acronym for a water pill. The UP andDOWN keys 55, 56 may be used to scan among the different medications. Ifone of the medications shown in field F7 is selected via the SELECT 53key, the information shown in FIG. 15B is displayed. The user may thenview different information about the selected medication (which isdiscussed in greater detail later).

FIGS. 15C-15F illustrate different options which may be scrolled to inaddition to FIG. 15B. In particular; the sub-options of the selectedPICK MED option shown in FIG. 15A includes information about themedication (FIG. 15B), the status of the medication (FIG. 15C), whetheror not the medication is to be renewed (FIG. 15D), information aboutmanual options (FIG. 15E), or entry into a mode that allows programmingof the medication and the appropriate regimen (FIG. 15F). Note thestatus, renew and manual sub-options may not be displayed if the deviceis locked, and the program option is preferably disabled if the deviceis locked.

FIGS. 16A-16R illustrates different options performed for the INFO MEDsub-option shown in FIG. 15B. In more detail, selection of thesub-option INFO MED shown in FIG. 15B results the display shown in FIG.16A. As shown, the last time the water pill was taken was on Monday at8:27 A.M. as defined by the fields F4, F5 and F7. If the last eventoccurred more than 7 calendar days ago, the information shown in FIG.16B is displayed. As shown, the field F5 indicates that the last waterpill was taken on November 18. Alternately, the display may show thenumber of days that have elapsed since the last dose of water pill wastaken.

In addition, to block entry of erroneous information into the last MEDsub-option shown in FIGS. 16A and 16B, the information shown in FIGS.16C and 16D are displayed at start-up, reset or modification of thegiven MED program. Further, using the UP or DOWN keys 55, 56 results inthe type of regimen being displayed as shown in FIG. 16E. As shown, theregimen type is displayed for the particular medication in field F5,which displays the three times a day regimen #3 shown in FIG. 9).Depending on the regimen, successive entries of the UP or DOWN keys 55,56 results in the information shown in FIG. 16F. As shown, theinformation includes the range values for the particular selectedregimen as shown in the fields F4, F5 and F7. FIGS. 16G-161 illustratethe total number of days for the fixed cycle regimen, the number of daysthe medication is to be taken in the fixed cycle regimen, and which dayof the fixed cycle is today's date, respectively.

FIGS. 16J and 16K illustrate information displayed for the MONTH CYCLEregimen #7 shown in FIG. 9. In more detail, FIG. 16J indicates thestarting day of the MONTH CYCLE that the medication is to be taken, andFIG. 16K indicates the last day of the MONTH CYCLE that the medicationis to be taken, inclusive of the day specified. Following the aboveregimen displays, either of the status displays shown in FIGS. 16L and16M is provided to the user. In particular, FIG. 16L displays theinformation indicating the medication is ON and should be taken at themedication alarm times. Using the UP key 55 in this display proceeds toa display indicating the first time of day the medication is to be taken(as shown in FIG. 16N). Further, if a medication is to be renewed, theappropriate renew information is displayed (as shown in FIG. 16R). FIG.16M indicates the medication alarm is disabled (i.e., OFF). FIGS.16O-16Q illustrates successive entries of the UP key 55 which displaysthe next 10 take times for the medications. Note FIG. 16Q indicates thata take occurs later than within the next 7 days. The 23 days shown infield F5 indicates the number of days from today when the medication isto be taken. Thus, with reference to FIG. 16Q, the user can see that themedication must be taken in 23 days. FIG. 16R shows informationindicating how many days from today the medication will need to berenewed. The renew alarm is activated on midnight of day 00 of therenew, for example. Thus, with reference to FIG. 16R, the user candetermine that the medication must be renewed in 12 days. Thisinformation is only displayed if the renew option is on.

FIG. 17 illustrates information displayed when the STATUS MED sub-optionshown in FIG. 15C is selected. As shown, the display field F5 in FIG. 17indicates the status is OFF. The status may be changed by using the UPand DOWN keys 55, 56 to toggle between the ON and OFF states. The SELECT53 key is pressed to select ON of OFF and the selection is accomplishedby a beep. If the medication has been transitioned from an OFF state toan ON state, the next take alarms are recalculated against the currenttime.

Turning now to the RENEW MED sub-option shown in FIG. 15D. Selection ofthe RENEW MED sub-option results in the information shown in FIG. 18A.As shown, the RENEW MED sub-option is in an OFF state. The UP and DOWNkeys 55, 56 can be used to toggle between the ON and OFF states.Selecting the OFF state via the SELECT 53 key causes the alarm4 to soundand the display returns to the NEXT option step S200 shown in FIG. 11 orother appropriate display. If the renew option is ON and selected, thealarm4 sounds and the information shown in FIG. 18B is displayed. The 00in field F5 designates the currently registered number of days prior tonotification to renew. The UP and DOWN keys 55, 56 may be used to adjustthis number between 0 and 99. Pressing the SELECT 53 key causesselection of the designated number. Thus, using FIGS. 18A and 18B, theuser can set the particular days in which the medication is to berenewed and may turn ON or OFF this feature. The MANUAL MED and PRGM MEDsub-options shown in FIGS. 15E and 15F are described later.

Turning now to FIGS. 19A-19D, which illustrate different options of theALARM BUZZ menu option step S210 shown in FIG. 11. Selection of theALARM MENU buzz option results in one of the displays shown in FIGS. 19Aand 19B. As shown, the user can toggle between setting the alarm to ahigh or low sound or vibration and to select the alarm to be ON orsilent. As shown in FIG. 19C, the user may set a desired tone for thealarm sound using the UP and DOWN keys 55, 56. FIG. 19D illustrates anoption in which the user may adjust the volume for the alarm sound.

Next, FIGS. 20A-20D illustrate different operations of the ALARM CLOCKmenu option step S212 shown in FIG. 11. Selection of the ALARM CLOCKoption causes the alarm4 to sound and results in the display shown inFIG. 20A. The time displayed in field F7 is the last time the alarm wasset for, and the information about whether the alarm is set to displayonce or daily in field F4 (note FIG. 20A illustrates the alarm being setto display once). The UP and DOWN keys 55, 56 may be used to scanbetween ON, OFF and SET options in field F5 and the SELECT 53 key may beused to select one of the options in the field F5. Selection of the OFFoption turns the alarm OFF, and selection of the option SET results inthe displayed information shown in FIG. 20B. As shown, the user is giventhe option of scanning between the ONCE or DAILY option in the field F5.Selecting either of the options in the field F5 results in the displayinformation shown in FIG. 20C (as shown in the field F4, the user hasselected the DAILY option). The user is also able to set the time atwhich the alarm is to sound using the UP and DOWN keys 55, 56. Note inFIG. 20D, the user has set an alarm to go off at 6:45 AM each day. Notethis alarm is different than an alarm that sounds when a medication hasbeen taken improperly.

FIGS. 21A-21D illustrate different options for the TRIP menu option stepS214 shown in FIG. 11. The TRIP option calculates the amount ofmedication (in dosage) needed over a specified period between two dates.Selection of the TRIP menu option causes the alarm4 to sound and resultsin the display shown in FIG. 21A. The user may use the UP and DOWN keys55, 56 to select the start day. Similarly, as shown in FIG. 21B, theuser may select the last day. After the last day is selected, theinformation shown in FIG. 21C is displayed. The user may then use the UPand DOWN keys 55, 56 to scan among the number of doses calculated foreach of the ON medications. For example, as shown in FIG. 21C, the usercan see that 112 doses will need to be taken during the start and lastdays entered into the device. This is particularly advantageous when avacation or trip is planned. Further, as shown in FIG. 21D, the user cansee that the medication should be renewed prior to beginning on thetrip. The number of doses are preferably calculated beginning atmidnight of the start date through one second before midnight of the dayfollowing the last day.

Turning now to FIGS. 22A-22M, which illustrate different options of theSET TIME menu option step S216 shown in FIG. 11. Note this feature isdisallowed if the device is in a LOCK mode. With the SET TIME option,the user may change the date and time. Selection of the SET TIME optionresults in the display shown in FIG. 22A. The information displayed inFIG. 22A indicates the user is to press the TIME 60 key and the SELECT53 key simultaneously to set the time. When these keys are pressed, theinformation shown in FIG. 22B is displayed. Here, the user may scrollbetween the twenty-four hour and AM/PM selection shown in field F7 usingthe UP and DOWN keys 55, 56. The 24 H option causes all times to bedisplayed as military time (i.e., 1:15 PM is displayed as 13:15).Selection of the CLOCK option shown in field F5 results in theinformation shown in FIG. 22C being displayed. Here the user may selectthe year.

Upon selection of the year, the user may choose the appropriate monthand date as shown in FIGS. 22D and 22E. Then, as shown in FIGS. 22F and22G, the user may select the time of day (note FIG. 22F illustrates thetime being displayed in standard AM/PM time, and FIG. 22G illustratesthe time being displayed in military time). Further, FIGS. 22H and 22Iillustrate a case in which it is not the first time change from when thedevice was powered up (note the above FIGS. 22A-22E illustrate settingthe time when the device is first powered on). FIG. 22H illustrates thecase for standard AM/PM time and FIG. 22I illustrates the case formilitary time. Note in this mode, the hour field can preferably be notchanged by more than 4 hours in either direction and the UP and DOWNkeys 55, 56 are ignored at the 4 hour limit. Also, the date and day arepreferably automatically changed when going backwards from 12:xx AM orforward from 11:xx PM. FIGS. 22J and 22K illustrate the minutes beingchanged. Thus, in reference to FIGS. 22H-22K, the user may change thehours and minutes of the time. These values are then selected and thealarm4 sounds resulting in the information displayed in FIG. 22L. Here,the user can toggle between FIGS. 22L and 22M to edit the time or savethe time.

Turning now to FIGS. 23A-23F, which illustrate the different useroptions the user may scroll through using the UP and DOWN keys 55, 56 inthe USER menu option step S218 shown in FIG. 11. In more detail, usingthe UP and DOWN keys 55, 56, the user may program options including aNAME (FIG. 23A), PHONE (FIG. 23B), MEALS (FIG. 23C), LOCK (FIG. 23D),EVENT (FIG. 23E) and COMM (FIG. 23E). Note some of the USER functionsare preferably limited to expert use and cannot be performed when thedevice is LOCKED. As a programming illustration, selection of the NAMEsub-menu option shown in FIG. 23A results in the display shown in FIG.23G. Here, the user may enter his or her name by using the UP and DOWNkeys 55, 56 in conjunction with the SELECT 53 key.

FIG. 24A illustrates selection of the LOCK sub-menu option shown in FIG.23D. The LOCK option controls limited access to the advance featuresthat may be LOCKED or UNLOCKED by toggling the field F5 using the UP orDOWN keys 55, 56. Further, a three digit code (password) is required toLOCK or UNLOCK the device. Once the code has been entered, selectionbetween UNLOCKED in FIG. 24B or LOCKED in FIG. 24C can be made.

FIG. 25A is similar to FIG. 23G and corresponds to the NAME sub-menuoption shown in FIG. 23A. Once this information has been entered in FIG.25A, the user may continue editing this information or save thisinformation using the UP and DOWN keys 55, 56 as shown in FIG. 25B.

Turning now to the MEALS sub-menu option shown in FIG. 23C. FIG. 25Cillustrates the selection of the MEAL sub-menu option in FIG. 23C inwhich no meals regimens are active (i.e., the user is requested to setthe times). Dressing the SELECT 53 key produces the display shown inFIG. 25F. If any medication has a meal time regimen association, theinformation shown in FIG. 25D is displayed. Note the user is cautionedto read the manual before programming the device. Pressing the SELECT 53key produces the display shown in FIG. 25E. This display functions in amanner similar to the TIME CHANGE display in that the TIME and SELECTkeys 53, 60 are required to be pressed concurrently to proceed withediting the meal times shown in FIGS. 25F and 25I. As shown in FIGS.25F-251, the user is able to modify the times the meals are to be taken.That is, the user can set breakfast time to be 8 AM. On the contrary, ifthe user worked a midnight shift, they could change the breakfast timeto be 11 PM, for example.

FIG. 25J illustrates an option in which the user is able to continueediting the entered meal time information or to save the information. Ifthe device is in a locked state, the meal times will be displayed bypressing the SELECT 53 key while the display reads as shown in FIG. 25C,but cannot be edited. Breakfast can preferably occur any time with lunchat least 4 hours later and dinner at least 5 hours after lunch. Allmeals preferably occur within a fourteen hour period, and after theselection of breakfast times, the device is preferably prevented fromillegal selection of lunch or dinner times.

Turning now to FIGS. 25K and 25L, which illustrate the operations of theEVENT user sub-menu option shown in FIG. 23E. Selection of the EVENTuser sub-menu option results in the display shown in FIG. 25K indicatingthe user may view a log of the medication thus taken. The UP and DOWNkeys 55, 56 may be used to scroll through the log events. An eventnumber greater than 2399 preferably indicates that logging has exceeded2400 events and has wrapped around, losing the earliest log events.Events logged include TAKE, SKIP, MISS (for missed medications exceedingthe TAKE time limit), MCHG (manual medications edit), NTIM (displaytimes at SAVE) and TCHG (displays time at start of EDIT time), forexample. Medication log times are saved chronologically at the time theevent occurred. As shown in FIG. 25L, the user can see that the lastentry in the EVENT log is Viagra on Friday, 8:34 AM. The EVENT log maybe cleared by the computer using the IR interface and is preferably notaffected by the RESET function. That concludes the description of theuser sub-options shown in FIGS. 23A-23F.

Turning now to the operations for programming a regimen (i.e., the PRGMMED sub-menu option shown in FIG. 15F). Programming of regimens forindividual medicines is accomplished by first selecting the MED menuoption step S208 shown in FIG. 11 and then selecting a medication asshown in FIG. 15A and then selecting the PRGM MED sub-menu option shownin FIG. 15F. Selection of the PRGM MED sub-menu option results in thedisplay shown in FIG. 26A. At this point, the user can enter an acronymfor the name of the medication. After the medication name is selected,the user can scan among the regimen options shown in FIG. 9. FIG. 26Billustrates selection of the once-a-day regimen #1 shown in FIG. 9.After selection of the regimen #1, the user enters the time of day inwhich to take the medication as shown in FIGS. 27A-27B. Upon completionof entering the time of day the medication is to be taken, the user isable to either further edit the entered information or save the enteredinformation as shown in FIGS. 27C-27D.

FIG. 28 illustrates the information entered for the AS-NEEDED regimen #6in FIG. 9. As shown in FIG. 28, the user is able to enter a timeinterval for this regimen. After the time interval is entered, the useris able to select the time of day similar to that as shown in FIGS.27A-27B. FIGS. 29A-29B illustrate the operations for programming the DAYof WEEK regimen #14 shown in FIG. 9. As shown in FIG. 29A, the user isgiven the option to select the appropriate ON/OFF designation for thespecified day and can scroll through the days as shown in FIG. 29B. Theselection process is repeated until the appropriate designations foreach day of the week has been entered. After the information for thelast day has been entered, the user is able to enter the time of day atwhich the medication is to be taken similar to that shown in FIGS.27A-27B.

The regimens with food, after meals and before meals (i.e., regimen #'s8, 9, 10 and 11 in FIG. 9) are programmed by selecting the particularregimen. Note, the choice can be made as to which meals are selected.The user can choose any or all of the breakfast, lunch and dinner meals(similar to how is performed in FIGS. 29A and 29B). Once a regimen isselected, a display similar to that shown in FIG. 27C is providedallowing the user to complete the data entry process. Note, it is alsopossible to only use the empty stomach and with food regimens #11 and#8.

Turning now to FIGS. 30A-30F, which illustrate the operations forprogramming the FIXED CYCLE regimen #12 and the MONTH cycle regimen #7shown in FIG. 9. The selection of the CYCLE results in the display shownin FIG. 30A. The UP and DOWN keys 55, 56 may be used to select betweenmonth long cycles and cycles of fixed duration (i.e., MONTH or FIXED infields F5 and F7, respectively). If the FIXED duration option isselected, the display shown in FIG. 30B is displayed. In this display,the user may select the total take days in the fixed cycle. Once thisvalue is selected, the number of take days may be entered in the displayshown in FIG. 30C. Upon selection of the number of take days, the userenters today's date in the fixed cycle. As shown in FIG. 30D, the userhas entered that today's date is the first day in the fixed cycle.

Upon selection of this value, the user may continue editing or savingthis information via the EDIT/SAVE display shown in FIG. 27C. FIGS. 30Eand 30F illustrate programming the MONTH cycle regimen #7 shown in FIG.9. As shown, the user enters the first take day of the month in FIG. 30Eand upon selection of this value, the user enters the last take day ofthe month in FIG. 30F. The user is then able to save or continue editingthis information as discussed above.

FIGS. 31A-31D illustrate operations for programming the custom regimen#0 shown in FIG. 9. As shown, when the custom regimen is selected, theuser is able to enter the first time a dose is to be taken as shown inFIGS. 31A and 31B. Preferably, the minute range allowed will not bedisplayed as earlier than one hour from the previous dose or laterwithin one hour from the first dose of the day. The UP and DOWN keys 55,56 and SELECT 53 key may be used to scan and select an appropriate taketime first by hour then by minute. After the first take time minute isselected, the next earliest take time will be displayed with the hoursblinking. Selection of both the hours and minutes indicates the end ofdose selection. Entry of the tenth time, entry of a take time on orafter 11 PM, or entry 00:00 AM causes the sequence to stop and theinformation shown in FIG. 31C to be displayed. The UP and DOWN keys 55,56 may be used to scan the hour in the plus range by 0.25 hours orfifteen minutes, for example. The range allowed is preferably inincrements of 0.25 hours and does not exceed the minimum time betweentwo doses. Once the number of plus hours is selected with the SELECT key53, the information shown in FIG. 31D is displayed.

Again, the user may scan the hour in the minus range by 0.25 hours, forexample. The range allowed is preferably in increments of 0.25 hours anddoes not exceed one quarter the minimum time between two doses or fourhours, whichever is less. Once the information is selected, the user maycontinue editing or save this program as discussed above. Further, notethat the plus and minus intervals holds for all settings in a givencustom regimen. The minimum interval between two doses is preferably onehour and the minimum plus/minus range is 0.25 hours.

Turning now to the MANUAL TAKE sub-menu option shown in FIG. 32A. TheMANUAL TAKE option may be selected by selecting the MED option step S208in FIG. 11 and then selecting a medication using the PICK MED sub-menuoption in FIG. 15A. Selection of these options results in the displayshown in FIG. 15A. Selecting the option in FIG. 15E results in thedisplay shown in FIG. 32A and pressing the TAKE 61 key results in thedisplay shown in FIG. 32B. Thus, the user is able to manually take ablue pill at Monday 2:10 AM and record the taking of the same. An alarm2sounds and returns to an appropriate display after the MANUAL TAKE isrecorded. In addition, it is preferable the MANUAL TAKE is operationalwith all medications irrespective of the ON/OFF status. Utilization ofthe MANUAL TAKE sequence results in the recording of the event in thenonvolatile memory and in the LAST MEDICATION sub-menu option shown inFIG. 16A. Although it is preferable the default of MANUAL TAKE isdisabled when the device is in a lock state, the IR interface may beused so this option is allowed even when the device is locked.

Turning now to FIG. 32C, which illustrates that the data stored as LASTin the display shown in FIG. 16A is updated each time a medication istaken. After a medication take is recorded LAST MED displays the day andtime a medication was last taken. When more than 7 days has elapsedsince the last dose of medication was taken the display indicates thenumber of days that have elapsed. The LAST MED display stops givinginformation about manual takes after 7 days have elapsed.

FIGS. 33A-33C illustrate special notifications provided to the userincluding the replacement of the battery in FIG. 33A, recharging of thebattery in FIG. 33B and renewing a medication in FIG. 33C. These alarmsare displayed in proximity to TAKE and EARLY events, thereby providingthe user with other useful information while his or her attention isfocused on the device. Thus, the notification for the batteryreplacement prescription renewal, or battery recharge can be displayedin conjunction with TAKE events. The UP and DOWN keys 55, 56 may be usedto scroll between this information.

FIGS. 34A-34F illustrate operations performed when the RESET 63 key inFIG. 10 is pressed. The RESET 63 key will clear all hand-held unitoption settings, TIME is reset to a start of the internal clock with theexception of the setting for the actual user name (which can be changedfrom the “NAME” user sub-menu option, but will maintain the previouslyset NAME). The description information entered at the level of the PCand the TAKE event data entries will be maintained. Upon activation ofthe reset 63 key, the user will be presented with the information shownin FIG. 34A. Only the SELECT 53 key is active at this time. Pressing theSELECT 53 key, the user is requested to enter their name and phonenumber as shown in FIGS. 34B-34C. The phone number may be entered usingthe UP and DOWN keys 55, 56 and the SELECT 53 key. Once the informationis entered, the user is given the option of editing or saving theentered information as described above. The current DATE and TIME arethen set as described above and as shown in FIG. 34D. The desired mealtimes are also set as shown in FIG. 34E and as described above. As shownin FIG. 34F, “NO TAKES” is displayed in the field F7. Use of the RESETbutton is not subject to the lock function of the hand-held unit.Further, activation of the RESET function will require use of apaperclip or other similar device and any parameter such as name andphone number as previously entered will not be altered by the RESETfunction. Note, with this feature a new record will be used with thereset function. Thus if a new user is taking over the device, he or shewill be able to enter the new data. However, if the same user was toreset the device, he or she would not need to reenter all information.Any previous events in the EVENT log will also remain saved. Only asingle time change (new time) event is logged at the TIME EDIT/SAVEevent.

Note that the phrase “make a selection” etc. discussed above correspondsto pressing the SELECT 53 key.

Further, as discussed above, the device includes an IR interface with aPC interface. In conjunction with the interface, the free standingdevice can download stored information to the PC and the PC will havethe capacity to download information to the freestanding unit regardingthe operational parameters. The exchange of the data between the freestanding unit and the PC can be accomplished in preferably less than oneminute when data is being uploaded from the device to the PC andpreferably in under 30 seconds when data is being downloaded to thedevice, for example.

The free standing unit also includes the nonvolatile memory that storesTAKE event information, patient/provider specific information and drugspecific information, for example. TAKE event information will includesufficient time data to allow calculation of the day and time when themedication was last taken; a medication identifier and a flag indicatingeither TAKE, SKIP, MANUAL TAKE or ABORT (time window closes). Thenonvolatile memory can store at least 60 days worth of such informationand a maximum of 40 events a day, for example, and thus the device willhave the capacity to store 60.times.40=2400 events. Note, that a timechange event will use space for two events, and as for a time changeevent, it is required to store the amount by which the time has changedbesides recording the instant at which the time was changed. The memoryis preferably non-erasable in the free standing unit, but an optionexists to erase TAKE event data via instructions from the PC.Additionally, each free standing unit produced preferably has a uniqueidentifier associated with it.

In addition, patient information entered at the level of the freestanding unit includes an eight character alpha/numeric identifier, mealtimes and a recalculate time, for example. Additional patient specificinformation can be downloaded from the PC to the device. This dataincludes a name, an ID number, an additional ID number, a daytime phonenumber, etc. With regard to the provider, the PC can download theinformation including an e-mail address, a fax phone number, a group IDnumber, etc.

Further, drug-specific information includes information that can begenerated at the level of the free standing unit and includes amedication acronym, the regimen and the regimen specific parameters asdescribed above. The PC also downloads additional drug-specific data toinclude a drug name, an NDC number and the medicine strength. Further,note that each free standing unit and software package has a uniqueidentifier that can be stored. At the level of the PC, a mechanism canevaluate any data that conflicts that might exist between the PC and thefree standing unit. Further, the PC will be able to command theactivation and inactivation of several parameters without any adverseeffect on operation of the free standing unit. These parameters includeSTATUS, MANUAL TAKE, RENEW and SET TIME, for example. The default modeof these parameters is that the feature is DISABLED. In addition to theindividual feature control, the LOCK status is required to be in theLOCKED status for the feature to be disabled.

Turning now to FIGS. 35A-35F, which illustrates operation for initiatingcommunication with a PC. To communicate with a PC, the device is put ina communication (COMM) mode by pressing the SELECT key 53 in the displayshown in FIG. 23F. Upon selection of this sub-menu option, theinformation shown in FIG. 35A is displayed. The UP and DOWN keys 55, 56may be used to toggle between the SET BAUD and the START options. If theSELECT key 53 is pressed when the START option is blinking, the devicegoes into the communication mode and waits for commands from the PC. Onan “end of communication command” from the PC, if no command is receivedfor 120 seconds, for example, or the MENU 54 key is pressed, the devicedrops out of the communication mode and returns to a default screen, forexample.

While the device is communicating with the PC, the message shown in FIG.35B is displayed. At termination of the COMM mode by any means, timeout, etc. from the PC or the MENU 54 key, the information shown in FIG.35C is displayed for at least 2 seconds, for example. During thisperiod, all medications that have been programmed via the IR interfacehave their take schedules calculated. The information shown in FIGS. 35Dand 35E may also be displayed in addition to either the above figures ifan attempt to communicate with the PC is made and a low batterycondition causes the device to power fail or restart. The display willpass through the IN PROGRESS display shown in FIG. 35D even if it was inEXIT SYNC shown in FIG. 35C already when the power failure occurred. Ifthe SELECT 53 key is pressed when the SET BAUD option is blinking, thedisplay shown in FIG. 35F is presented. The UP and DOWN keys 55, 56 maybe used to scroll through a list of appropriate baud rates. A user maythen select a desired baud rate.

The event switch shown in the first, second, third and fourthembodiments should be of a size such that activation by an elderlyperson would not be difficult while at the same time safeguardingagainst accidental activation. The reset button is of a size such thatactivation thereof requires a thin, needle-shaped object so as tosafeguard against the accidental turning off of the device.

The present invention also includes a time change algorithm, which isimplemented to ensure that when a user changes the current time (e.g.,due to daylight savings time, etc.), the next TAKE times areappropriately recalculated. That is, changing the clock time in thedevice, associated with daylight savings times, east to west coasttravel, etc., necessitates readjusting as appropriate the variousprogram regimens to assure that the time interval between doses of themedication is appropriately maintained. To achieve this object, analgorithm according to the present invention is implemented to ensurethat a minimum time interval is maintained between doses of themedication. The algorithm tests each medication to recalculate a newTAKE time based on the LAST take in conjunction with the time change.For example, the following algorithm may be used:

1) L_(T)=the last time a medication was taken. No take is 0;

2) K_(R)=regimen specific constant; the minimum interval between doses;

3) T_(NI)=the first next calculated take time;

4) T_(NX)=the next consecutively calculated take time;

5) N_(T)=the operational next take time;

6) T_(D)=L_(T)+K_(R);

7) N.T=T_(NI) if T_(D) is < or = to T_(NI);

8) N_(T)=T_(NX) if T_(D) is < or = to T_(NX);

Thus, if the interval between the last TAKE of the medication and theNEXT take time of the medication is less than or equal to the regimenspecific minimal interval constant, the next TAKE is that which has beenpreviously calculated prior to the time change. However, if the intervalis less than that specified by the regimen specific interval, acalculation is successively performed with the NEXT calculated taketimes until the condition is met where the next TAKE time is separatefrom the last take time by an interval equal to or greater than theregimen specific minimum time interval constant (K_(R)) K_(R) can varyfrom regimen to regimen and can have values that preferably range from1.0 to 0.01 times the time interval between two doses of medication inthe regimen. In the current embodiment, the K_(R) is assigned to therespective regimens as follows:

1/DAY, withFOOD (1 dose per day), emptSTOM (1 dose per day), CYCLE FIXEDand CYCLE MONTH—16 hr; 2/D—8 hr: 3/DAY—5 hr; 4/DAY—3 hr; breakfast anddinner withFOOD and emptSTOM—3 hr; D of W, XXHR, and CUST—⅔ times theminimum interval between two doses of medication. The K_(R) values canbe stored permanently in the device or the K_(R) values specific to agiven medication may be assigned by a data entry procedure with thefreestanding unit of through the PC-IR interface.

The interval by which the time is changed can also have significanteffects on the calculation of time for an appropriate dose of a givenmedication. For this reason, a constraint that the interval of timechange not exceed more than plus or minus 24 hr is established. In thecurrent embodiment, the maximum time change is limited to plus or minus4 hr. This is because the device offers dosing regimens of greater than24 hr and because fixed K_(R) values are assigned on a permanent basis.If these constraints are changed expansion of the time change restraintsis possible. The imposition of both the time limit value and the K_(R)value for calculation are aimed at assuring patient safety by not havingthe device erroneously advise the patient to take two doses ofmedication so close together that there is medical danger.

In conjunction with the time change, the time for opening of the earlytake window is evaluated and if necessary recalculated in compliancewith the requirements as set forth below. Note, these calculations aremade on the basis of elapsed time.

Adjustment of the early take window according to the present inventionis to prevent a situation in which a medication can be taken at a latestpoint in the early time take window and then in the earliest time in thenext take window, which results in the medication being taken inintervals that are too close to each other. In more detail, theprescription compliance device offers the patient the life stylelatitude to take medication during a time window preceding thecalculated take time (early take) and extending to a time after thecalculated take time (late take). However, a situation may arise wheremedication taken at the late take time and then at an early take timeviolate the minimum interval requirements as defined by the K_(R)values. For this reason, the time for opening of the early take windowafter taking a dose of medication is tested and recalculated byapplication of the following algorithm:

9) T_(E)=the default early window opening time;

10) E_(T)=the operational early opening window time;

11) E_(T)=T_(D) if T_(D)>T_(E)

12) E_(T)=T_(E) if T_(D)< or = to T_(E)

Thus, the opening of the early take window is adjusted to the time ofthe last take plus the value of K_(R) if this sum produces a time thatis later than the default. If the value of the last time plus K_(R) isearlier than the default, the early window is opened at the defaulttime.

The present invention also relates to a transient take feature. Thisfunction is provided by using the IR interface and the PC. For example,a healthcare provider or pharmacist gives the user or patientmedication, but wants the patient to begin the medication as soon aspossible. Using the transient take feature, the healthcare provider mayprogram the device to begin taking the medication immediately, and thenease into one of the programmed regimens. For example, assume that achild is very ill and requires antibiotics to be taken everyday. If thechild was to receive the prescription at 4 pm, for example, and was veryill and needed to take the medication right away, the pharmacist mayprogram the device so as to allow the child to take the antibiotic at 4PM, and then set the next time to be 10 AM, rather than at the regimentime of 8 AM. On the following day, the regimen could then beimplemented so that the child takes the medication at 8 AM every day.Using this feature, the pharmacist may also program the device so thatthe patient is signaled to take the medication after a certain medicalprocedure, etc., is completed. For example, assume the patient is tobegin taking antibiotics after stitches are removed from a region of thebody. Thus, using this feature, the pharmacist or healthcare providermay program the device to begin taking medication in 5 days (after thestitches have been taken out) and to end on a particular date.

In more detail, when the prescription compliance device is programmed bya healthcare provider via the PC interface it may be desirable that taketimes be set to permit the user to get on a specific schedule or avoidmissing a dose of a specific medication. For this reason, the transienttake algorithm has been developed for programming specific take timesinto the device. At the PC, the operator has the opportunity to evaluatethe various take events for each medication and determine if theadjustment is desirable. If this is the case, the healthcare providerenters a time at which a dose of medication is to be taken, which isseparate from the standard regimen logic. The healthcare provider alsohas the option to instruct the prescription compliance device to skipone or several of the future take events. The firmware of theprescription compliance device is so structured that it implements theseinstructions as communicated via the interface.

FIGS. 36A-36B illustrate a front view and a side view of theprescription compliance device according to the fourth embodiment,respectively.

As shown in FIG. 36A, the device includes the display fields F1, F5 andF7 similar to that shown in FIG. 10. Also included are the TIME 60 key,SKIP 62 key, TAKE 61 key, MENU 54 key, UP and DOWN keys 55, 56 and theSELECT 53 key. FIG. 36B illustrate a fold out stand 99 that puts thedevice at a convenient viewing angle. Note that the embodiment shown inFIGS. 36A-36B differ from the device shown in FIGS. 8A-8C in that thedevice shown in FIGS. 36A-36B is a free standing device and is notattached to the medication bottle, for example.

The present invention may also be used to gather medical information.Through the PC interface, appropriate medical emergency information suchas the name of physicians, relations and healthcare providers andappropriate contact information, the patients medical status includingmedical conditions, medical history, allergies, and any otherinformation which might be of value to the healthcare provider in anemergency situation may be entered. It is also possible to access thisinformation either at the level of the device itself or though the PCinterface.

People currently use a variety of electronic aids such as personaldigital assistants, cellular telephones, pocket calculators, musicstorage, reproduction and receiving devices, etc. According to thepresent invention, the functions of the prescription compliance devicemay be integrated with a cellular telephone. Such a medi-phone providesusers with the option of having both a cellular telephone and theprescription compliance device to carry around as a single unit. Notonly would this provide better convenience, but it provides the userwith significant cost savings since components such as case, LCD,battery, charger, electronic circuit components and microprocessors maybe shared between the two functionalities.

Another feature includes combining the prescription compliance devicewith a personal digital assistant. The advantages of this is similar tothose afforded by combination with the telephone. It is also be possibleto integrate the cellular telephone, personal digital assistant and theprescription compliance device as a single unit with even greateradvantages and savings. Similarly combination of the prescriptioncompliance device with personal musical devices provide advantages.

The multi-use device is particularly advantageous in that implementingthe features of the prescription compliance device within in a phone,etc. hides the fact that the person is taking the medication. That is,for people with diseases such as Aids, several medications must be takenduring the day. Thus, if an ill person was in a public area (such as atrain station), for example, it would be obvious to everyone within thevicinity that the person was using a medication device. However,according to the present invention, the medication functions of theprogramming compliance device may be implemented within the cellularphone. This hides the fact that the person is taking medication and isless embarrassing. Further, an elderly person may not be interested inhaving a cell phone, which can be problematic for a son or daughter,etc. who wishes to determine the status of their elderly parentsthroughout the day. That is, many elderly people may find cell phones tobe not necessary. However, according to the present invention, theprogramming options of the prescription compliance device may beintegrated within the cell phone, which will then make the elderlyperson who does not want a cell phone, to use the cell phone as aprescription compliance device. Thus, because the elderly person now usethe cell phone, it will be easier to stay in contact with them. Thisalso results in the cellular manufacturers, selling more cell phones.

In addition, the present invention also is particularly advantageous inthat it logs information, which is medical information or any otherinformation. That is, the device can be set so that it alerts someonethat an action must be taken, and the alarms may be set using the presetregimens or may be set using the custom regimen. The actions scheduledmay include the gathering of some data. In a medical scenario, it may betaking the temperature, blood glucose, blood pressure, pulse rate orother similar things that require entry of numeric and/or alphabeticdata. For example, assume that the physician wishes the patient to taketheir blood pressure one hour after taking a Viagra pill. According tothe prescription compliance device of the present invention, an alarmmay be set alerting the person to take their blood pressure or gatherother data.

The device also provides the user the opportunity to enter relevantdata. Procedures similar to those used for entering the name and phonenumbers discussed above may be used for this purpose. The data thusroutinely logged may also be downloaded to the PC for analysis.Alternatively, the log data may be viewed using the device (i.e., usingthe event log function). In addition to entering data, the device iscapable of storing lists that can be reviewed and a yes or no answer canbe provided and is logged. Medically, this could be done for things suchas a headache, back pain, sore arm etc. That is, the user is able toenter possible side effects related to the medication, which may then beused to analyze different side effects for different people. Inaddition, for a watchman it could be to open, light on, alarm set, etc.The options can be tiered to make access easy through GI, neurologic,vascular, and items may be selected and then sub items addressed. Datafrom this feature can be prompted, logged and handled in a mannersimilar to that discussed above. Further, data entry protocols may bestored in the firmware of the device. Alternatively, the capacity ofdata entry may be stored in the firmware of the device and then tailoredby using a PC. An alarm could alert the user to enter numeric data. ThePC will then specify a screen display to indicate what data is to beentered and then provide a field in which to make the numeric entry.With menu driven data, the user would be alerted to enter informationregarding a topic and then be taken through a menu similar to the menusdiscussed above.

Electronic Configuration and Programming Parameters

This invention may be conveniently implemented using a conventionalgeneral purpose digital computer or microprocessor programmed accordingto the teachings of the present specification, as will be apparent tothose skilled in the computer art. Appropriate software coding canreadily be prepared by skilled programmers based on the teachings of thepresent disclosure, as will be apparent to those skilled in the softwareart. The invention may also be implemented by the preparation ofapplication specific integrated circuits or by interconnecting anappropriate network of conventional component circuits, as will bereadily apparent to those skilled in the art.

The present invention includes a computer program product which is astorage medium including instructions which can be used to program acomputer to perform a process of the invention. The storage medium caninclude, but is not limited to, any type of disk including floppy disks,optical discs, CD-ROMs, and magneto-optical disks, ROMs, RAMs, EPROMs,EEPROMs, magnetic or optical cards, or any type of media suitable forstoring electronic instructions.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the above teachings. The specificparameters mentioned in conjunction with the description of theinvention have been set forth solely for illustrative purposes and arenot limiting of the scope of the invention in any way. It is thereforeto be understood that within the scope of appended claims, the inventionmay be practiced otherwise than as specifically described herein.

1. A method for monitoring patient compliance to medical therapy,comprising: repeatedly measuring therapy compliance of a patient andstoring such information on a device; uploading the therapy compliancemeasurements stored on the device to a computing unit; evaluatingpatient compliance based on the received therapy compliancemeasurements; identifying instances where patient compliance fails tomeet predetermined compliance requirements; and sending a notification,about one or more instances, to a party based on patient compliancewhereby action can be taken by that party.